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Why Alvesco?

Alvesco Inhalation Aerosol offers:

  • Small particle size designed to get into the small airways of the lungs
  • Anti-inflammatory properties that may help reduce inflammation in the airways
  • Demonstrated improvements in lung function
  • Demonstrated reduction in asthma symptoms

Ask your doctor if Alvesco Inhalation Aerosol is right for you!

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.

Important Limitations of Use:

  • ALVESCO is NOT indicated for the relief of acute bronchospasm
  • ALVESCO is NOT indicated for children under 12 years of age

Using Alvesco

As a controller medicine, Alvesco needs to be used regularly, as directed by your healthcare provider.

  • It may take 4 weeks or longer after you start using Alvesco Inhalation Aerosol for your asthma symptoms to get better.
  • Do not stop using Alvesco Inhalation Aerosol even if you are feeling better, unless your healthcare provider tells you to.
  • If your symptoms do not improve or get worse, call your healthcare provider.

If you or your child 12 or older has asthma, speak with your doctor about whether Alvesco could be right for you or your child.

When Not to Use Alvesco

  • Alvesco should NOT be used to treat sudden symptoms of asthma (also known as bronchospasm) or asthma attacks. Always carry your quick-relief inhaler with you, to use for sudden asthma symptoms.
  • If you are allergic to ciclesonide or any of the ingredients in the Alvesco Inhalation Aerosol, do not use it.

Reference:

Alvesco® Inhalation Aerosol Prescribing Information. Marlborough, United Kingdom: Sunovion Pharmaceuticals Inc.; January 2013.

How to Take Alvesco

Alvesco comes in an inhaler device and should be inhaled through the mouth.

Alvesco Inhalation Aerosol is available in 2 strengths: 80 mcg/puff and 160 mcg/puff. The inhaler has a convenient built-in dose indicator, so you know how many puffs are left.

The starting dose of Alvesco will depend on what medications you have received before. Talk with your doctor for more information.

The Parts of Your Inhaler

Alvesco Inhalation Aerosol comes as a canister that fits into an actuator with a dose indicator.

  • Do not use the actuator with a canister of medicine from any other inhaler.
  • Do not use Alvesco Inhalation Aerosol canister with an actuator from any other inhaler.

Priming Your Inhaler

  • Before using your Alvesco Inhalation Aerosol for the first time, and any time it has not been used for more than 10 days, it will need to be primed.
  • Make sure the canister is firmly placed in the mouthpiece each time you use the inhaler.
  • Remove the cap from the plastic mouthpiece.
  • Hold the actuator upright, between your thumb, forefinger, and middle finger.
  • You do not need to shake the Alvesco inhaler before using it.
  • Prime the inhaler by releasing 3 test sprays into the air, away from your face.
  • Check the dose indicator display window after the priming sprays and before the first use to make sure it shows that there are 60 sprays left in your Alvesco Inhalation Aerosol unit. If there are not 60 sprays left after the initial priming sprays, return it to the pharmacy.

Using Your Alvesco Inhaler

Step 1.

  • Remove the cap from the mouthpiece

Step 2.

  • Hold the actuator upright, between your thumb, forefinger, and middle finger with the mouthpiece pointing towards you.

Step 3. Breathe Out

  • Breathe out fully through your mouth, letting as much air out of your lungs as possible.
  • Close your lips around the mouthpiece, keeping your tongue below it.

Step 4. Breathe In

  • While breathing in deeply and slowly through your mouth, press down on the center of your dose indicator with your finger until the canister stops moving inside the actuator.
  • When you have finished breathing in, hold your breath for about 10 seconds, or for as long as is comfortable.

Note: It’s normal to hear a soft click from the indicator as it counts down during use.

Step 5. Breathe Out

  • Take your finger completely off the center of the dose indicator and remove the inhaler from your mouth. Breathe out gently.
  • Replace the cap to keep the mouthpiece clean.
  • Rinse your mouth with water and spit it out. Do not swallow.

Cleaning Your Inhaler

Please note you should not wash or put any part of your Alvesco Inhalation Aerosol unit in water or any other liquids.

STEP 1

Clean the mouthpiece weekly with a clean dry tissue, both inside and out.

STEP 2

Wipe over the front of the small hole where the medicine comes out with a dry, folded tissue.

How to Tell If Your Canister Is Empty

  • Your Alvesco Inhalation Aerosol unit is fitted with a dose indicator display which shows you how much of your medicine is left after each use.
  • Each canister of Alvesco Inhalation Aerosol contains enough medicine for you to spray your medicine 60 times. This does not count the first sprays used for priming.
  • The dose indicator display counts down by 10 and will move every tenth time you take a puff (i.e., 60-50-40, etc.).
  • The dose indicator display window will turn red when there are only 20 sprays left. This means that you need to replace your inhaler soon.
  • When the dose indicator display window reads “0” you should throw away your Alvesco Inhalation Aerosol unit.
  • Although your Alvesco Inhalation Aerosol unit is fitted with a dose indicator display to help determine the number of sprays left, you should keep track of the number of sprays used from each canister of your Alvesco Inhalation Aerosol unit.

Reference:

Alvesco® Inhalation Aerosol Prescribing Information. Marlborough, United Kingdom: Sunovion Pharmaceuticals Inc.; January 2013.

Safety Information

Here is some important safety information you should know about Alvesco Inhalation Aerosol.

Keep in mind that the side effects observed in clinical studies may not necessarily reflect all the side effects observed in practice.

The most common side effects of Alvesco Inhalation Aerosol reported in clinical trials include:

  • headache
  • swelling of nose and throat (nasopharyngitis)
  • swelling of the sinuses (sinusitis)
  • throat pain
  • upper respiratory infection
  • joint pain (arthralgia)
  • nasal congestion
  • pain in arms, legs, and back

Other possible serious side effects include:

Thrush, a yeast infection of your nose, mouth, or throat
Tell your healthcare provider if you have discomfort or pain in your throat, have hoarseness in your voice or have any redness or white colored patches in your mouth or throat. Rinse your mouth after you use your Alvesco Inhalation Aerosol.

Immune system problems that may increase your risk of infections
You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use Alvesco Inhalation Aerosol. Symptoms of an infection may include:

  • Fever
  • Pain
  • Aches
  • Chills
  • Feeling tired
  • Nausea
  • Vomiting

Adrenal insufficiency
Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Your healthcare provider will follow you closely if you take steroids by mouth and are having them decreased (tapered) or you are being switched to Alvesco Inhalation Aerosol. People have died while steroids are being decreased and when people have been switched from steroids by mouth to inhaled steroids like Alvesco. If you are under stress, such as with surgery, after surgery or trauma, you may need steroids by mouth again.

Call your healthcare provider right away if you have the following symptoms of adrenal insufficiency:

  • Tiredness
  • Weakness
  • Dizziness
  • Nausea that does not go away
  • Vomiting that does not go away

Decreased bone mass (bone mineral density)
People who use inhaled steroid medicines for a long time may have an increased risk of decreased bone mass which can affect bone strength. Talk to your healthcare provider about any concerns you may have about bone health.

Slowed or delayed growth in children
A child’s growth should be checked regularly while using Alvesco Inhalation Aerosol.

Eye problems such as glaucoma and cataracts
If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use Alvesco Inhalation Aerosol.

Increased wheezing (bronchospasm) can happen right away after using Alvesco Inhalation Aerosol. Stop using Alvesco Inhalation Aerosol and use an inhaled fast-acting bronchodilator (rescue inhaler) right away if you are wheezing.

These are not all of the possible side effects with Alvesco Inhalation Aerosol. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Reference:

Alvesco® Inhalation Aerosol Prescribing Information. Marlborough, United Kingdom: Sunovion Pharmaceuticals Inc.; January 2013.